Prevention for Positives: An RCT Among Vietnamese HIV-positive IDU
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![](https://webarchive.library.unt.edu/web/20130315211310im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
The purpose of this study is to determine whether a combined individual and structural level stigma reduction intervention is effective in reducing high risk injecting and sexual behaviors among HIV positive injecting drug users.
Condition | Intervention |
---|---|
HIV |
Behavioral: Individual level Behavioral: Structural level Behavioral: Individual level standard of care Behavioral: Structural level standard of care |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
Official Title: | Prevention for Positives: A Randomized Controlled Trial Among Vietnamese HIV-positive Injecting Drug Users |
- HIV injecting risk behavior [ Time Frame: 2 years ] [ Designated as safety issue: No ]Change in self-reported use of new injecting equipment
- HIV sexual risk behavior [ Time Frame: 2 years ] [ Designated as safety issue: No ]Change in self-reported condom use during sexual intercourse
- HIV incidence [ Time Frame: 2 years ] [ Designated as safety issue: No ]Change in HIV incidence among network members
- Perceived HIV-related stigma [ Time Frame: 2 years ] [ Designated as safety issue: No ]Change in self-reported perceived HIV-related stigma among index participants
Estimated Enrollment: | 2032 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Individual level |
Behavioral: Individual level
Index participants will participate in standard HIV VCT supplemented with 2 posttest counseling sessions, followed by 2 post-test skill-building support groups for HIV positive IDUs.
Behavioral: Structural level standard of care
Posters and billboards on HIV/AIDS transmission, leaflets on HIV/AIDS transmission available in health station, 15-minute monthly public broadcasts (via the village loudspeaker) on the consequences of HIV/AIDS and the number of HIV cases in the country and province will be delivered in communities.
|
Experimental: Structural level |
Behavioral: Structural level
Community members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers.
Behavioral: Individual level standard of care
The education materials that are currently offered in Thai Nguyen will be delivered didactically by health workers on 1) the HIV situation in Vietnam; 2) consequences of drug use; 3) routes of HIV transmission; and 4) options for drug treatment.
|
Experimental: Combined individual & structural level |
Behavioral: Individual level
Index participants will participate in standard HIV VCT supplemented with 2 posttest counseling sessions, followed by 2 post-test skill-building support groups for HIV positive IDUs.
Behavioral: Structural level
Community members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers.
|
Active Comparator: Standard of Care |
Behavioral: Individual level standard of care
The education materials that are currently offered in Thai Nguyen will be delivered didactically by health workers on 1) the HIV situation in Vietnam; 2) consequences of drug use; 3) routes of HIV transmission; and 4) options for drug treatment.
Behavioral: Structural level standard of care
Posters and billboards on HIV/AIDS transmission, leaflets on HIV/AIDS transmission available in health station, 15-minute monthly public broadcasts (via the village loudspeaker) on the consequences of HIV/AIDS and the number of HIV cases in the country and province will be delivered in communities.
|
Detailed Description:
This study is a randomized controlled trial among HIV-positive injecting drug users (IDUs) to reduce high risk injecting and sexual behaviors in Thai Nguyen, Vietnam. We will be conducting this study in collaboration with the Thai Nguyen Centre for Preventive Medicine (CPM). We will compare standard HIV voluntary counseling and testing (VCT) to an intervention that adds a continuum of psychosocial support for HIV-positive IDUs. The intervention consists of a two-tiered approach that addresses structural and individual level barriers to risk reduction: 1) The structural level of the intervention consists of community-based programs and targets HIV stigma that is a primary obstacle to risk reduction for HIV-positive individuals; 2) The individual level of the intervention consists of 2 HIV posttest counseling sessions and 2 skill-building support groups for HIV-positive IDUs. Our research questions for the overall project are:
- What is the impact of perceived HIV-related stigma on disclosure, social support, and coping among IDUs?
- What roles do disclosure, social support, and coping play in facilitating the reduction of HIV-risk behaviors
- Are combined individual and structural level interventions more effective in reducing injecting and sexual behaviors among HIV-positive IDUs than individual or structural interventions alone and more effective than the standard HIV VCT?
![](https://webarchive.library.unt.edu/web/20130315211310im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Index participant
Inclusion Criteria:
- laboratory confirmed HIV positive diagnosis
- able and wiling to bring an injecting network member for screening
- injected drugs in previous 6 months
- planned residence in Thai Nguyen for next 24 months
Exclusion Criteria:
- unwilling to provide locator information
- unable to participate in group counseling sessions due to psychological disturbance, cognitive impairment or threatening behavior
- currently participating in other HIV or drug use intervention activities
Network member participant
Inclusion Criteria:
- laboratory confirmed HIV negative diagnosis
- injected or shared drug paraphernalia in past 6 months
- interacts at least once a week with index participant
Exclusion Criteria:
- unwilling to provide locator information
- having psychological or cognitive impairment
- currently participating in other HIV intervention
![](https://webarchive.library.unt.edu/web/20130315211310im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Vietnam | |
Center for Preventive Medicine | |
Thai Nguyen, Vietnam |
Principal Investigator: | Vivian F Go, PhD | Johns Hopkins Bloomberg School of Public Health |
![](https://webarchive.library.unt.edu/web/20130315211310im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT01689545 History of Changes |
Other Study ID Numbers: | 5R01DA022962 |
Study First Received: | September 18, 2012 |
Last Updated: | September 18, 2012 |
Health Authority: | National Institutes of Health: National Institute on Drug Abuse |
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
HIV drug abuse social stigma Vietnam |
Additional relevant MeSH terms:
HIV Seropositivity HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on March 14, 2013